SUPPLY CHAIN ARTICLES

  • FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

    The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

  • Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions

    Overall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem. 

  • Plasmid Production: 3 Key Takeaways For mRNA Manufacturing

    Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid. 

  • mRNA Vaccines: Key Considerations For Development & Manufacturing

    As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more. 

  • The Cell-Free Revolution: Breaking The Plasmid DNA Bottleneck

    I was excited to be given the opportunity to sit down with Jodi Barrientos, CEO, Ribbon Bio, to learn more about the current state of the synthetic DNA space. In the following Q&A, Barrientos and I discuss some of the synthetic DNA industry’s biggest goals and the challenges that stand in the way of bringing synthetic plasmids more commonly into the mRNA development paradigm. 

  • ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!)

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

SUPPLY CHAIN VIDEOS

With benefits across applications, nanoplasmids are designed to replace antiquated bacterial backbones, while eliminating antibiotic markers that can cause regulatory concerns.

Together, Life Edit Therapeutics’ April Sena and Sanofi’s Troiano share their perspectives on raw material quality & IP-related considerations for managing the supply chain for next-generation RNA modalities.

Three experts in cold chain management walk through the advantages of end-to-end platforms for bulk drug substance management.

Sanofi’s Sumit Luthra shares several of the analytical and manufacturing innovations/improvements he’s watching and waiting for that will improve our knowledge of LNP composition, structure, function, and quality.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS